Comparing Intubation Rates in the Delivery Room by Interface

NCT05609773 | Unknown

• 1 other identifier: 1783154
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Although the majority of premature neonates \< 30 weeks gestion require positive pressure ventilation (PPV) at birth, the optimal interface to provide PPV has not been determined. Preferably this support would be provided by non-invasive means to prevent the development of bronchopulmonary dysplasia. Resuscitation with a face mask, single nasal tube, nasal prongs, and/or LMA are all approved methods of resuscitation per NRP as of 2010. Face masks have been associated with more dead space, air leak and airway obstruction however are the most commonly used interface. Recently, the Trigeminal Cardiac Reflex has been described, which can be induced with the placement of a facemask, resulting in bradycardia and apnea. Bi-nasal prongs (RAM cannula) have been found in studies to be associated with lower intubation rates in the delivery room (down to 24 weeks gestation), less need for epinephrine, chest compressions, and subsequent invasive ventilation. In addition to the potential practical advantages of bi-nasal prong resuscitation, there is evidence to suggest that ventilation through the nose may stimulate the subepithelial receptors of the upper airways causing an increase in respiratory rate and depth.

Conditions

Ventilator Lung; Newborn

Outcome Measures

Primary Outcomes (1)

• Comparing Intubation Rates in the Delivery Room by Interface

  We hypothesize that there will be at least a 40% reduction in the rate of intubation for patients born \< 30 weeks' gestation when bi-nasal prongs are utilized for neonatal resuscitation vs face mask.

  3 years

Eligibility Criteria

• Age: 0 Weeks - 30 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

All resuscitated infants \< 30 weeks' gestation born at OSF SFMC.

You may qualify if:

• All resuscitated infants \< 30 weeks' gestation born at OSF SFMC

You may not qualify if:

• Diagnosis of congenital diaphragmatic hernia No PPV needed, or no resuscitation desired due to major congenital anomalies or peri- viable status

Sponsors & Collaborators

• University of Illinois College of Medicine at Peoria: lead
• Children's Hospital of Illinois: collaborator
• OSF Healthcare System: collaborator

Study Sites (1)

University of Illinois College of Medicince

Peoria, Illinois, 61604, United States

RECRUITING

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ashley Fischer, MD

  University of Illinois College of Medicine at Peoria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Fischer, MD

CONTACT

309-624-8977; Ashley.M.Fischer2@osfhealthcare.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 8, 2022
• Study Start: September 22, 2022
• Primary Completion: September 22, 2025
• Study Completion: September 22, 2025
• Last Updated: December 20, 2022

Record last verified: 2022-11

Locations

US (1)